AVAILABLE MEDICINE FOR Emtricitabine and Tenofovir Disoproxil Fumarate
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Ricovir EM Tablets
$16.00 - $80.00 |
$16.00 - $80.00 |
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Tenvir Em
$20.00 - $100.00 |
$20.00 - $100.00 |
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Tenof EM Tablets
$21.00 - $120.00 |
$21.00 - $120.00 |
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Truvada (emtricitabine / tenofovir disoproxil) Tablets - PrEP
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Emtricitabine/Tenofovir Fisoproxil Fumarate is a fixed-dose combination antiretroviral medication used for the treatment and prevention of HIV infection. This combination belongs to the nucleoside reverse transcriptase inhibitor (NRTI) class of drugs. Emtricitabine also goes by its abbreviation FTC, while Tenofovir Disoproxil Fumarate is often called TDF. Together, they form a robust dual-NRTI backbone that serves as an essential part of many HIV treatment regimens.
More Information About Emtricitabine/Tenofovir Disoproxil Fumarate
Emtricitabine and Tenofovir Disoproxil Fumarate represent two distinct molecules that work in synergy when combined. Here is some background on this important combination:
Chemical Structure & Formula
Emtricitabine (FTC): C₈H₁₀FN₃O₃S
Tenofovir Disoproxil Fumarate (TDF): C23H34N5O14P
Emtricitabine is a synthetic nucleoside analogue of cytidine. Its chemical structure features a modified cytosine base with a fluorine atom at the 5-position of the cytosine ring and an oxathiolane ring.
Tenofovir Disoproxil Fumarate is a prodrug of Tenofovir, an acyclic nucleoside phosphonate (nucleotide) analogue of adenosine monophosphate. The Disoproxil Fumarate component enhances the oral bioavailability of tenofovir.
Discovery & Development
The development of Emtricitabine Tenofovir Disoproxil Fumarate represents a milestone in HIV treatment. Emtricitabine was developed by researchers at Emory University and later acquired by Gilead Sciences.
Tenofovir was discovered through a collaboration between researchers at the Czech Academy of Sciences and Gilead Sciences.
The combination of these two drugs into a single tablet was a significant advancement in HIV treatment adherence. Gilead Sciences developed this fixed-dose combination.
Approval & Regulatory Status
The U.S. Food and Drug Administration (FDA) first approved Emtricitabine and Tenofovir Disoproxil Fumarate tablets 200mg/300mg (brand name Truvada) in 2004 for the treatment of HIV infection. In a groundbreaking move, the FDA expanded its approval in 2012 to include pre-exposure prophylaxis (PrEP) for HIV prevention in high-risk individuals. This was the first time an oral medication was approved for HIV prevention.
The European Medicines Agency (EMA) followed with similar approvals, and the World Health Organization (WHO) has included this combination on its List of Essential Medicines.
Mode of Action
The dual mechanism of action of Emtricitabine Tenofovir Disoproxil Fumarate provides a robust barrier against HIV reproduction. Both components are nucleoside reverse transcriptase inhibitors that target the same enzyme but in slightly different ways. It creates a synergy effect that enhances efficacy while reducing the risk of viral resistance.
Uses of Emtricitabine/Tenofovir Disoproxil Fumarate
If you want to learn what is Emtricitabine and Tenofovir Disoproxil Fumarate used for, you need to understand the combination has two primary FDA-approved indications:
HIV-1 Treatment: Emtricitabine and Tenofovir Disoproxil Fumarate tablets 200mg/300mg serve as a backbone in combination antiretroviral therapy (cART) for treating HIV-1 infection in adults and pediatric patients weighing at least 17 kg. It is typically used alongside a third antiretroviral agent, such as an integrase inhibitor, non-nucleoside reverse transcriptase inhibitor, or protease inhibitor.
HIV Prevention (PrEP): Perhaps most notably, Emtricitabine And Tenofovir Disoproxil Fumarate tablets 200mg/300mg PrEP are approved for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk. This preventive use has revolutionized HIV prevention strategies worldwide.
Off-Label Uses: While not officially approved for these purposes, Emtricitabine and Tenofovir Disoproxil Fumarate are sometimes used in:
Post-exposure prophylaxis (PEP) following potential HIV exposure.
Hepatitis B virus (HBV) treatment, as Tenofovir, has activity against HBV (though other formulations of tenofovir may be preferred).
Prevention of mother-to-child transmission of HIV in specific scenarios.
How Does Emtricitabine-Tenofovir Disoproxil Fumarate Works?
The effectiveness of Emtricitabine/Tenofovir Disoproxil Fumarate lies in its targeted action against a critical step in the HIV life cycle.
Mechanism of Action
Both components work by inhibiting HIV reverse transcriptase, the enzyme responsible for converting viral RNA into DNA- which is a crucial step in HIV replication:
Emtricitabine is a synthetic nucleoside analog of cytidine. Once inside cells, it is phosphorylated by cellular enzymes to form Emtricitabine triphosphate, which competes with natural deoxycytidine triphosphate for incorporation into the growing viral DNA strand. When incorporated, it terminates DNA chain elongation because it lacks the 3'-hydroxyl group needed to form the next phosphodiester bond.
Tenofovir Disoproxil Fumarate is a prodrug that, once absorbed, is converted to Tenofovir in the bloodstream. Tenofovir then undergoes phosphorylation within cells to form tenofovir diphosphate, which competes with the natural substrate deoxyadenosine 5'-triphosphate for incorporation into DNA. Like Emtricitabine, it acts as a chain terminator and prevents further elongation of viral DNA.
Effectiveness Factors
Several factors influence how well Emtricitabine-Tenofovir Disoproxil Fumarate works:
Food: Taking Emtricitabine and Tenofovir Disoproxil Fumarate tablets 200mg/300mg with food increases tenofovir absorption, which potentially enhances efficacy.
Adherence: The effectiveness of this medication, especially for PrEP, is highly dependent on consistent daily dosing. Studies show that protection drops significantly with missed doses.
Renal Function: Since both drugs are eliminated through the kidneys, decreased renal function can lead to higher drug concentrations and potential toxicity.
Pre-existing Resistance: The presence of certain HIV resistance mutations can reduce effectiveness in treatment scenarios.
Common Side Effects of Emtricitabine/Tenofovir Disoproxil Fumarate
Most people tolerate Emtricitabine and Tenofovir Disoproxil Fumarate well, but like all medications, it can cause side effects:
Mild Side Effects
Headache
Nausea
Diarrhea
Fatigue
Dizziness
Skin rash
Abdominal pain
These symptoms often resolve within the first few weeks of treatment as the body adjusts to the medication.
Moderate to Severe Side Effects
More serious adverse effects of Emtricitabine/Tenofovir Disoproxil Fumarate can include:
Renal Impairment: Tenofovir can cause kidney problems, including decreased kidney function and Fanconi syndrome (a disorder of the kidney tubules).
Decreased Bone Mineral Density: Long-term use may lead to bone mineral density loss, potentially increasing fracture risk.
Lactic Acidosis: Rarely, NRTIs including Emtricitabine and Tenofovir Disoproxil Fumarate can cause lactic acidosis (buildup of lactic acid in the bloodstream) and severe hepatomegaly (liver enlargement) with steatosis (fat in the liver).
Immune Reconstitution Inflammatory Syndrome (IRIS): When used for HIV treatment, the restoring immune system may respond to previously hidden infections, causing inflammation.
Hepatitis B Flare: In patients co-infected with HIV and hepatitis B, discontinuation of Emtricitabine-Tenofovir Disoproxil Fumarate can cause severe acute exacerbations of hepatitis B.
When to Seek Medical Help?
Contact a healthcare provider immediately if you experience:
Signs of kidney problems (decreased urination, swelling of feet/ankles)
Bone pain or fractures
Symptoms of lactic acidosis (unusual muscle pain, difficulty breathing, stomach pain with nausea and vomiting, cold or blue extremities, dizziness, or rapid heartbeat)
Unusual weakness or tiredness
Yellowing of the skin or eyes
Dark urine or pale stools
Regular monitoring of kidney function and bone mineral density is recommended for individuals on long-term therapy with Emtricitabine and Tenofovir Disoproxil Fumarate tablets 200mg/300mg.
Available Medicines for Emtricitabine/Tenofovir Disoproxil Fumarate
Emtricitabine/Tenofovir Disoproxil Fumarate is available in several branded and generic formulations:
Brand Name | Manufacturer | Strengths |
Truvada | Gilead Sciences | 200 mg/300 mg |
Tenvir-EM | Cipla | 200 mg/300 mg |
Ricovir-EM | Mylan | 200 mg/300 mg |
Tavin-EM | Emcure | 200 mg/300 mg |
The combination is primarily available as oral tablets, and the standard dosage is 200mg/300mg. It refers to 200 mg of Emtricitabine and 300 mg of Tenofovir Disoproxil Fumarate in each tablet. These medications should be taken once daily or as directed by a healthcare provider.
For pediatric patients, the medication may be available in lower-strength tablets based on weight-based dosing requirements.
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Frequently Asked Questions
What is Emtricitabine/Tenofovir Disoproxil Fumarate used for?
It is used for HIV treatment, pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), and in some cases, chronic Hepatitis B treatment.
Can pregnant or breastfeeding women take this medication?
Yes, it is often prescribed during pregnancy to prevent mother-to-child transmission of HIV. Consult a doctor for guidance.
How effective are Emtricitabine And Tenofovir Disoproxil Fumarate tablets 200mg 300mg for PrEP at preventing HIV?
When taken consistently as directed, Emtricitabine and Tenofovir Disoproxil Fumarate tablets 200mg/300mg PrEP can reduce the risk of sexually acquired HIV-1 infection by more than 90%. However, effectiveness is highly dependent on adherence.
How long does it take for PrEP to be effective?
It takes about 7 days for rectal tissue protection and 20 days for blood and vaginal tissue protection.
Can I take Emtricitabine/Tenofovir Disoproxil Fumarate if I have kidney problems?
This medication is not recommended for individuals with severe kidney impairment (estimated creatinine clearance below 30 mL/min). For those with mild to moderate kidney dysfunction, dose adjustments and frequent monitoring may be necessary.
Does this medication have any drug interactions?
Yes, it can interact with:
Other HIV medications (risk of resistance or toxicity).
NSAIDs (may increase kidney damage risk).
Rifampin, anticonvulsants, and certain herbal supplements can reduce its effectiveness.
Will Emtricitabine and Tenofovir Disoproxil Fumarate tablets 200mg/300mg affect my hormonal birth control?
Emtricitabine/Tenofovir Disoproxil Fumarate does not interact with hormonal contraceptives, so it should not reduce their effectiveness. Women taking this medication for HIV treatment or PrEP can continue using their regular birth control methods without concern about reduced contraceptive efficacy.
Can I stop taking the medication if I feel better?
No, stopping the medication without medical advice can lead to viral resistance and treatment failure. Always consult your doctor before discontinuing.
Can Emtricitabine and Tenofovir Disoproxil Fumarate be used for children?
This tablet is approved for HIV treatment in children weighing at least 17 kg (about 37 pounds). PrEP, is approved for adolescents weighing at least 35 kg (about 77 pounds), who are at risk of HIV infection. Pediatric dosing is based on weight, and your child's healthcare provider will determine the correct dosage.
What happens if I miss a dose?
If you miss a dose, take it as soon as possible. If it is close to your next dose, skip it and resume your normal schedule.
Disclaimer: This content is for informational purposes only and should not replace professional medical advice. Emtricitabine/Tenofovir Disoproxil Fumarate is a prescription medication that should only be used under the supervision of a qualified healthcare provider. Always consult your doctor before starting, stopping, or changing any medication regimen.
Reference:
https://www.webmd.com/drugs/2/drug-91482/truvada-oral/details
https://clinicalinfo.hiv.gov/en/drugs/Emtricitabine-tenofovir-disoproxil-fumarate/patient
https://www.ema.europa.eu/en/medicines/human/EPAR/Emtricitabine-tenofovir-disoproxil-mylan
https://pmc.ncbi.nlm.nih.gov/articles/PMC4757763/
https://www.hiv.uw.edu/page/treatment/drugs/tenofovir-disoproxil-fumarate-Emtricitabine
